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• W3138914653 abstract "The Watch the Spot Trial is a cluster-randomized, pragmatic clinical trial comparing two guideline-based strategies for surveillance of small lung nodules. The study utilizes a passive enrollment approach in which eligible patients are notified of the study and given the opportunity to opt-out. While such pragmatic trials enable large studies to be efficiently implemented in real-world settings, they pose unique ethical considerations. In this exploratory study, we provide a summary of patient questions and concerns that may be useful for future studies. Throughout the enrollment period, we documented incoming patient contacts in a database by copying emails verbatim and taking notes for phone calls. To analyze these contacts, we performed a conventional content analysis. After creating an initial codebook, we first identified simple requests to opt-out. For the remaining contacts that contained questions or comments, one primary and two secondary coders independently applied the codes to a random 10% sample of patient contacts. We discussed results to achieve consensus on discordant cases, revised the codebook, and repeated this process with another sample to ensure inter-coder reliability. The primary coder applied final codes to all contacts. We calculated the proportion of contacts for which each code was present. Of the 17,291 patients that were notified of the study, 857 (5%) reached out to the study team. Of these, there were 248 simple requests to opt-out. There were 609 with questions or comments eligible for the content analysis, 111 of whom also opted out. The most common reasons for patient contacts included opt-outs, clarification about study procedures, and being unaware of the lung nodule prior to research notification (Table 1). Some patients expressed anger or stress around learning about their lung nodule this way. Relatively few patients expressed concerns about the access to and sharing of protected health information (PHI).Table 1Conventional Content Analysis ResultsCode numberCode descriptionContacts containing code (n, %)*Example of patient contact notes1Simple opt-out248, 28.9Patient left message stating they opt out.1.1Opt-out with other questions or concerns111, 13.0Patient wishes to opt-out (in addition to other questions or concerns in codes listed below).2Study procedures clarification292, 34.1Asked if participating would mean additional traveling and CT scans.2.1Explicit consent provided40, 4.7Replied to notification “I agree to participate.”3Nodule care84, 9.8Said their doctor described their nodule as scar tissue and are unsure if we’re referring to the same thing.3.1Unaware of nodule115, 13.4Had not heard about the nodule until receiving notification letter.4.1PHI sharing with research team20, 2.3Asked how the study team got this information about them.4.2PHI sharing outside of health system22, 2.6Said they did not want their personal information transferred.5Ineligible7, 0.8Doctor told patient there was no lung nodule. After looking into the case the team realized they were erroneously enrolled due to programming error .6Survey technical support38, 4.4Patient could not figure out how to electronically sign their survey consent form.7Deceased13, 1.5Family member let us know the patient had recently passed away.8Non-member7, 0.8Let us know they recently left the health care system.9Misc16, 1.9Sent a long email complaining about a health care issue unrelated to the study.10Unknown or undocumented15, 1.8Left a voicemail saying they had questions, but we were unable to ever reach them.E.1**Angry or upset32, 3.7Said they are angered by the fact that they are finding out this way.E.2**Stress, worry, or anxiety24, 2.8Said that they are very worried about their nodule and need to speak someone.*% of out 857 total contacts. Codes are not mutually exclusive. **E codes were used as supplemental codes only, most often to augment code groups 3 and 4. Open table in a new tab *% of out 857 total contacts. Codes are not mutually exclusive. **E codes were used as supplemental codes only, most often to augment code groups 3 and 4. We identified several insights based on patient contact issues. Confusion about study procedures reinforces the importance of having dedicated study staff to respond to inquiries. Patients being previously unaware of and sometimes distressed about their nodule highlights the need to include the whole care team when implementing trials in real-world settings. The few concerns about PHI access and sharing warrant close involvement of an institutional review board. Even when the public health benefits of well-designed, pragmatic, passive enrollment trials are thought to outweigh the ethical risks, patient perspectives are an invaluable resource for minimizing inconveniences and miscommunications when designing future studies." @default.
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• W3138914653 date "2021-03-01" @default.
• W3138914653 modified "2023-10-17" @default.
• W3138914653 title "FP02.01 Patient Responses to Passive Enrollment into a Large, Pragmatic Clinical Trial: A Qualitative Content Analysis" @default.
• W3138914653 doi "https://doi.org/10.1016/j.jtho.2021.01.073" @default.
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